中文摘要：

目的：评价中药分期序贯治疗方案对轻、中度溃疡性结肠炎的缓解率、安全性以及缓解后6个月内复发率。方法：按照多中心、随机、对照、非劣效性研究设计,将4个临床中心的239例轻、中度溃疡性结肠炎患者采用中药分期序贯治疗（试验组）或者阳性对照药物美沙拉嗪肠溶片治疗（对照组）,疗程24周,比较两组患者缓解率、用药安全性以及两组进入缓解的患者6个月内的复发率。结果：治疗结束时,中药试验组缓解率77.5%,西药对照组缓解率74.2%,经非劣效性检验,中药试验组的缓解率非劣效于美沙拉嗪肠溶片对照组（P〈0.05）。安全性监测显示,试验组与对照组不良反应发生率差异无统计学意义。而随访6个月内,试验组复发率明显低于对照组（P〈0.05）。结论：对于轻、中度溃疡性结肠炎患者,中药分期序贯治疗方案的临床缓解率非劣效于美沙拉嗪肠溶片,中药试验组的安全性良好,并且能明显降低治疗后6个月内的复发率。

英文摘要：

objective： To evaluate the remission rate,safety and the rate of recurrence of within 6 months after remission of the sequential stages of Chinese medicine treatment on mild to moderate ulcerative colitis.Methods： According to the multi-center,randomized,controlled,noninferiority study design,239 patients with mild to moderate ulcerative colitis in the four clinical centers were treated with sequential stages of Chinese medicine treatment（experimental group） or positive control drug mesalazine enteric-coated tablets treatment（control group） for 24 weeks,and compared with the remission rate,recurrence of within 6 months after remission and safety of two groups.Results： In the end of treatment,the response rate of Chinese medicine treatment group was 77.5%;comparison group was 74.2%,in the non-inferiority test,the response rate of experimental group is non-inferiority to mesalazine enteric-coated tablets control group（P〈0.05）.And followed up for 6 months,the recurrence rate of treatment group was significantly lower than the control group（P〈0.05）.Security monitoring shows that there was no statistically significant difference the incidence of adverse reactions of the experimental group and the control group.Conclusion： For mild to moderate ulcerative colitis patients,the clinical remission rate of traditional Chinese medicine treatment program for sequential stages is non-inferiority to mesalazine enteric-coated tablets,and the security of Chinese medicine experimental group is better and the recurrence rate can be significantly reduced within 6 months after treatment.